Sinergium Biotech
Pharmaceutical formulations, generic medicines and healthcare products.
Sinergium Biotech manufactures pharmaceutical formulations, generic medicines and healthcare products from its Buenos Aires operations. The company supplies pharmacy channels, hospital buyers, healthcare distributors or export customers across its listed primary markets.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Buenos Aires, Argentina
- Founded
- 2009
- Website
- sinergiumbiotech.com
- Categories
- Medical & Healthcare Supplies, Supplements & Wellness
- Markets
- Argentina, Brazil, Chile, Colombia
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- domain-registered (green), checked 2026-08-12 Domain registry record
- sanctions-clear (green), checked 2026-08-12 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- debarment-clear (green), checked 2026-08-12 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- registered-manufacturer (green), checked 2026-08-21 Superintendencia de Regulacion Sanitaria de El Salvador, listado de productos farmaceuticos con registro sanitario vigente
Claimed certifications, not confirmed by us
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Food supplements sold in the EU follow Directive 2002/46/EC: most member states require a notification to the national authority before the first sale. European Commission (supplements)
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)